Agency Information Collection Activities; Proposed Collection; Comment Request; Web-Based Pilot Survey To Assess Allergy to Cosmetics in the United States, 55896-55898 [2018-24441]
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Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices
approach to data exchange? This might
include timing (procurement, fiscal
year, or legislative cycles), cost,
availability of required expertise,
needed regulatory change, impacts on
current practices, etc.
5. If a more standards-based approach
to data exchange were adopted, what
kinds of technical assistance or training
would you anticipate needing, if any?
ACF appreciates any and all
comments on the above questions, or
related recommendations. Comments
will be considered carefully and used to
inform the development of a planned
Notice of Proposed Rulemaking, which
is anticipated to be published in the
spring of 2019.
Dated: October 25, 2018.
Lynn A. Johnson,
Assistant Secretary for Children and Families.
[FR Doc. 2018–24459 Filed 11–7–18; 8:45 am]
BILLING CODE 4184–79–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3442]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Web-Based Pilot
Survey To Assess Allergy to
Cosmetics in the United States
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on a pilot study
entitled ‘‘Web-based Pilot Survey to
Assess Allergy to Cosmetics in the
United States.’’
DATES: Submit either electronic or
written comments on the collection of
information by January 7, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before January 7,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:51 Nov 07, 2018
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at the end of January 7, 2019. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–3442 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Webbased Pilot Survey to Assess Allergy to
Cosmetics in the United States.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
E:\FR\FM\08NON1.SGM
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Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Web-Based Pilot Survey To Assess
Allergy to Cosmetics in the United
States; OMB Control Number 0910—
New
I. Background
In the past 40 years, the cosmetics
industry, as well as consumer behaviors
and expectations related to cosmetics,
have evolved. Technological and
scientific advances have been made in
cosmetics production, manufacturing,
marketing, and usage, while consumer
access to information about cosmetic
products and ingredients has expanded,
because of the internet and social media
influences. Most notably, multiple
cosmetic products such as lotions,
perfume, body wash, hand wash,
shampoo, deodorant, hair spray, baby
wipes, nail polish, etc. are used daily by
nearly everyone in the United States,
including infants, children, adults,
geriatric populations, healthy people,
and individuals with medical
conditions.
Evidence indicates that the
prevalence of allergies in the U.S.
population is increasing (Ref. 1).
However, no publicly available data has
been collected on the prevalence of
adverse reactions to cosmetic products
since 1975 (Ref. 2). FDA proposes a
pilot study to collect the data needed for
a current and detailed understanding of
the impact of allergens on consumer use
of cosmetics. In addition to updating
our knowledge about cosmetics, this
new information collection is consistent
with FDA’s efforts to improve public
awareness of adverse events associated
with FDA-regulated products. In
December 2016, FDA decided to make
public the adverse event data in the
Center for Food Safety and Applied
Nutrition (CFSAN) Adverse Events
Reporting System (CAERS). CAERS (and
its imminent successor the CFSAN
Adverse Events Management System or
CAEMS) provides the public with
transparent access to all food and
cosmetic related adverse events reported
to FDA. However, the information that
we have collected and which will be
collected through CAERS is an
underestimate of adverse events to
cosmetics in the United States, as not
every adverse event is reported by
consumers through CAERS because
some consumers are not aware of
CAERS or some choose not to report.
To obtain additional relevant data,
FDA proposes to conduct a pilot study.
‘‘Web-based Pilot Survey to Assess
Allergy to Cosmetics in the United
States.’’ The objective of the current
55897
effort is to collect information needed
for a more current understanding of the
prevalence of adverse reactions to
cosmetics. FDA proposes to conduct an
exploratory consumer web-based survey
to collect data on consumer use of
cosmetic products, the frequency of
adverse events believed to be caused by
allergens in cosmetics, consumer
awareness of the problem, and actions
(if any) taken to avoid the allergens.
The proposed survey will use a 20minute web-based questionnaire to
collect information from 1,000 Englishspeaking adult members of a
probability-based web-enabled research
panel maintained by a contractor.
Selected panel members will be sent an
email invitation to participate in the
survey. After clicking on the link in the
email invitation, panelists will be
directed to the online instrument. On
the first screen, panelists will provide
disclosure information which includes
informed consent and be asked if they
would like to proceed with the survey.
Consenting respondents will be
prompted to complete the survey. After
OMB approval of this collection and
prior to the full-scale survey, a pretest
will be conducted with 100 respondents
randomly selected from the panel.
The web-based panel is designed to be
representative of the U.S. adult
population. This representation is
achieved through address-based
sampling where every U.S. adult with
an address (including those who do not
have a landline phone number) has an
equal probability of being selected for
participation.
This pilot study is part of the
Agency’s continuing effort to
understand the impact of allergens on
cosmetics.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
daltland on DSKBBV9HB2PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Study component
Total annual
responses
Pretest invitation ...............................
Pretest ...............................................
Survey invitation ................................
Survey ...............................................
200
100
1,667
1,000
1
1
1
1
200
100
1,667
1,000
Total ...........................................
........................
........................
........................
1 There
Average burden per response
0.033
0.333
0.033
0.333
(2 minutes) .............................
(20 minutes) ...........................
(2 minutes) .............................
(20 minutes) ...........................
7
33
55
333
...........................................................
428
are no capital costs or operating and maintenance costs associated with this collection of information.
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55898
Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices
II. References
The following references are on
display with the Dockets Management
Staff (see ADDRESSES) and are available
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday; these are not available
electronically at https://
www.regulations.gov as these references
are copyright protected.
1. Peiser, M., T. Traulau, J. Heidler, et al.,
‘‘Allergic Contact Dermatitis: Epidemiology,
Molecular Mechanisms, In Vitro Methods
and Regulatory Aspects. Current Knowledge
Assembled at an International Workshop at
BfR, Germany.’’ Cellular and Molecular Life
Sciences, 69:763–781, 2012.
2. Westat, Inc. ‘‘An Investigation of
Consumers’ Perceptions of Adverse Reactions
to Cosmetic Products.’’ Final report
submitted to U.S. Department of Health,
Education, and Welfare, Food and Drug
Administration. June 1975.
Dated: November 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24441 Filed 11–7–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0742]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Registration of
Producers of Drugs and Listing of
Drugs in Commercial Distribution
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by December
10, 2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0045. Also
include the FDA docket number found
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SUMMARY:
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in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Registration of Producers of Drugs and
Listing of Drugs in Commercial
Distribution—21 CFR Part 207; OMB
Control Number 0910–0045—Extension
This information collection supports
FDA’s drug establishment registration
and listing regulations and associated
guidance intended to assist respondents
in this regard. Requirements for drug
establishment registration and drug
listing are set forth in section 510 of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360), and section
351 of the Public Health Service Act (42
U.S.C. 262). Section 224 of the Food and
Drug Administration Amendments Act
of 2007 (Pub. L. 110–85) amended
section 510(p) of the FD&C Act to
require electronic drug establishment
registration and drug listing.
Regulations implementing these
provisions are established under part
207 (21 CFR part 207). Except as
provided in § 207.65, all information
submitted must be transmitted to FDA
in electronic format by using our
electronic drug registration and listing
system, in a form that we can process,
review, and archive. Establishment
registration information helps FDA
identify who is manufacturing,
repacking, relabeling, and salvaging
drugs and where those operations are
performed. Drug listing information
gives FDA a current inventory of drugs
manufactured, repacked, relabeled, or
salvaged for commercial distribution.
Both types of information facilitate
implementation and enforcement of the
FD&C Act and are used for many
important public health purposes.
I. Registration Under Part 207
Unless otherwise exempt under
section 510(g) of the FD&C Act or
§ 207.13, all manufacturers, repackers,
relabelers, and salvagers must register
each domestic establishment that
manufactures, repacks, relabels, or
salvages a drug, or an animal feed
bearing or containing a new animal
drug, and each foreign establishment
that manufactures, repacks, relabels, or
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
salvages a drug, or an animal feed
bearing or containing a new animal
drug, that is imported or offered for
import into the United States. When
operations are conducted at more than
one establishment and common
ownership and control among all the
establishments exists, the parent,
subsidiary, or affiliate company may
submit registration information for all
establishments.
Private label distributors who do not
also manufacture, repack, relabel, or
salvage drugs are not required to register
under part 207. FDA will accept
registration or listing information
submitted by a private label distributor
only if it is acting as an authorized agent
for and submitting information that
pertains to an establishment that
manufactures, repacks, relabels, or
salvages drugs.
Under § 207.21, domestic
manufacturers, domestic repackers,
domestic relabelers, and domestic drug
product salvagers must complete initial
registration of each establishment no
later than 5 calendar days after
beginning to manufacture, repack,
relabel, or salvage a drug. In addition,
foreign manufacturers, foreign
repackers, foreign relabelers, and foreign
drug product salvagers must register
each establishment before the drug is
imported or offered for import into the
United States.
The information that must be
provided to FDA for registration is
described in § 207.25 and includes the
following: (1) Name of the owner or
operator of each establishment; if a
partnership, the name of each partner; if
a corporation, the name of each
corporate officer and director, and the
place of incorporation; (2) each
establishment’s name, physical address,
and telephone number(s); (3) all name(s)
of the establishment, including names
under which the establishment
conducts business or names by which
the establishment is known; (4)
registration number of each
establishment, if previously assigned by
FDA; (5) a Unique Facility Identifier in
accordance with the system specified
under section 510 of the FD&C Act; (6)
all types of operations performed at
each establishment; (7) name, mailing
address, telephone number, and email
address of the official contact for the
establishment, as provided in
§ 207.69(a); and (8) additionally, with
respect to foreign establishments subject
to registration, the name, mailing
address, telephone number, and email
address must be provided for: (a) The
U.S. agent, as provided in § 207.69(b);
(b) each importer in the United States of
drugs manufactured, repacked,
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]]>Agencies
[Federal Register Volume 83, Number 217 (Thursday, November 8, 2018)]
[Notices]
[Pages 55896-55898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24441]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3442]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Web-Based Pilot Survey To Assess Allergy to Cosmetics
in the United States
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on a pilot study entitled ``Web-based Pilot Survey to
Assess Allergy to Cosmetics in the United States.''
DATES: Submit either electronic or written comments on the collection
of information by January 7, 2019.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 7, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 7, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-N-3442 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Web-based Pilot Survey to Assess
Allergy to Cosmetics in the United States.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party.
[[Page 55897]]
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
Federal Agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information before submitting
the collection to OMB for approval. To comply with this requirement,
FDA is publishing notice of the proposed collection of information set
forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Web-Based Pilot Survey To Assess Allergy to Cosmetics in the United
States; OMB Control Number 0910--New
I. Background
In the past 40 years, the cosmetics industry, as well as consumer
behaviors and expectations related to cosmetics, have evolved.
Technological and scientific advances have been made in cosmetics
production, manufacturing, marketing, and usage, while consumer access
to information about cosmetic products and ingredients has expanded,
because of the internet and social media influences. Most notably,
multiple cosmetic products such as lotions, perfume, body wash, hand
wash, shampoo, deodorant, hair spray, baby wipes, nail polish, etc. are
used daily by nearly everyone in the United States, including infants,
children, adults, geriatric populations, healthy people, and
individuals with medical conditions.
Evidence indicates that the prevalence of allergies in the U.S.
population is increasing (Ref. 1). However, no publicly available data
has been collected on the prevalence of adverse reactions to cosmetic
products since 1975 (Ref. 2). FDA proposes a pilot study to collect the
data needed for a current and detailed understanding of the impact of
allergens on consumer use of cosmetics. In addition to updating our
knowledge about cosmetics, this new information collection is
consistent with FDA's efforts to improve public awareness of adverse
events associated with FDA-regulated products. In December 2016, FDA
decided to make public the adverse event data in the Center for Food
Safety and Applied Nutrition (CFSAN) Adverse Events Reporting System
(CAERS). CAERS (and its imminent successor the CFSAN Adverse Events
Management System or CAEMS) provides the public with transparent access
to all food and cosmetic related adverse events reported to FDA.
However, the information that we have collected and which will be
collected through CAERS is an underestimate of adverse events to
cosmetics in the United States, as not every adverse event is reported
by consumers through CAERS because some consumers are not aware of
CAERS or some choose not to report.
To obtain additional relevant data, FDA proposes to conduct a pilot
study. ``Web-based Pilot Survey to Assess Allergy to Cosmetics in the
United States.'' The objective of the current effort is to collect
information needed for a more current understanding of the prevalence
of adverse reactions to cosmetics. FDA proposes to conduct an
exploratory consumer web-based survey to collect data on consumer use
of cosmetic products, the frequency of adverse events believed to be
caused by allergens in cosmetics, consumer awareness of the problem,
and actions (if any) taken to avoid the allergens.
The proposed survey will use a 20-minute web-based questionnaire to
collect information from 1,000 English-speaking adult members of a
probability-based web-enabled research panel maintained by a
contractor. Selected panel members will be sent an email invitation to
participate in the survey. After clicking on the link in the email
invitation, panelists will be directed to the online instrument. On the
first screen, panelists will provide disclosure information which
includes informed consent and be asked if they would like to proceed
with the survey. Consenting respondents will be prompted to complete
the survey. After OMB approval of this collection and prior to the
full-scale survey, a pretest will be conducted with 100 respondents
randomly selected from the panel.
The web-based panel is designed to be representative of the U.S.
adult population. This representation is achieved through address-based
sampling where every U.S. adult with an address (including those who do
not have a landline phone number) has an equal probability of being
selected for participation.
This pilot study is part of the Agency's continuing effort to
understand the impact of allergens on cosmetics.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Study component Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Pretest invitation............ 200 1 200 0.033 (2 7
minutes).
Pretest....................... 100 1 100 0.333 (20 33
minutes).
Survey invitation............. 1,667 1 1,667 0.033 (2 55
minutes).
Survey........................ 1,000 1 1,000 0.333 (20 333
minutes).
------------------------------------------------ ---------------
Total..................... .............. .............. .............. ................ 428
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 55898]]
II. References
The following references are on display with the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; these are not
available electronically at https://www.regulations.gov as these
references are copyright protected.
1. Peiser, M., T. Traulau, J. Heidler, et al., ``Allergic
Contact Dermatitis: Epidemiology, Molecular Mechanisms, In Vitro
Methods and Regulatory Aspects. Current Knowledge Assembled at an
International Workshop at BfR, Germany.'' Cellular and Molecular
Life Sciences, 69:763-781, 2012.
2. Westat, Inc. ``An Investigation of Consumers' Perceptions of
Adverse Reactions to Cosmetic Products.'' Final report submitted to
U.S. Department of Health, Education, and Welfare, Food and Drug
Administration. June 1975.
Dated: November 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24441 Filed 11-7-18; 8:45 am]
BILLING CODE 4164-01-P
